Össur ICEROSS LOCKING Instrucciones De Uso página 4

ENGLISH
Medical Device
DESCRIPTION
The device is a silicone liner that covers the residual limb and provides
an interface between the residual limb and the socket of the prosthesis.
The device provides a secure suspension to the prosthesis, protection of
the residual limb, and comfort.
A locking liner either has a fixed or an interchangeable distal attachment.
A cushion liner has no distal attachment and needs to be used together
with a sleeve that holds vacuum.
INTENDED USE
The device is a prosthetic interface with suspension properties intended
to be used as part of a system that replaces a missing lower limb.
Suitability of the device for the prosthesis and the patient must be
evaluated by a healthcare professional.
The device must be fitted and adjusted by a healthcare professional.
Indications For Use and Target Patient Population
• Lower limb amputation and/or congenital deficiency
• No known contraindications
The impact level for the device is listed in the Table below.
Transtibial Liners
Iceross Dermo
Iceross Dermo
Iceross Dermo
Iceross Dermo
Iceross Comfort
Iceross Comfort
Protect Locking
Protect Cushion
First
Sensitive Locking
Iceross Original Locking
®
Iceross Stabilo
Iceross Dermo
Iceross Synergy Locking
®
Iceross Synergy Cushion
®
Iceross Activa Cushion
®
Iceross Sport Locking
®
Locking
®
Uniform Locking
®
Cushion
®
Uniform Cushion
®
Locking
®
Cushion
®
Junior Locking
®
Junior Locking
®
Impact Level
The device is for low to
moderate impact use, e.g.,
walking.
The device is for low to high
impact use, e.g., walking and
occasional running.
The device is for moderate to
extreme impact use, e.g.,
walking, running, and sports.
The device is for high to extreme
impact use, e.g., fast walking,
running, and sports.
4